Member Info for JohnnyB1

Let's hope it is more than a dead mouse bounce.

Might it be, as some have suggested, that she is in possession of inside information?

Did she know that the share price was going to drop and the reasons behind this? and hence the hurried RNS?

OR Might it be because the conditions of her options award have not been met?

RNS 21 April’23: Options were given to Cossery and S Davies for 3 million and 1 million shares (respectively) at an exercise price of 17.5 pence.

The conditions attached to these is not too onerous, it states “With no vesting criteria other than to remain in employment.”

Compare this with LD’s 4.5 pence options.

RNS 13 July’23: The exercise period for 3.85 million share options awarded to Lindy Durrant, on 30 July 2020 will be extended from 30 July 2023 to 30 July 2026:-

“These options have an exercise price of 4.5 pence each. ALL OTHER CONDITIONS OF THE AWARD REMAIN THE SAME.” (Capitals are mine for emphasis)

So, what are the conditions for LD’s options?

I refer to page 6 (Note 1) of financial accounts for year end 30 April 2016 referring to these same share options, this states “Performance hurdle of 45p share price for 30 consecutive dealing days. In addition sale of company for in excess of £25 million”. (These options had an expiry date of 14 July 2020):-

https://www.scancell.co.uk/Data/Sites/1/media/fininfo/scancell-holdings-annual-report-30-april-2016-.pdf

A RNS was issued 4 September 2020 stating that new share options were issued on 30 July 2020 (For the same numbers of shares at 4.5p). These share options will expire on 30 July 2023 and replace previously issued share options that expired on 14 July 2020.

https://www.lse.co.uk/rns/SCLP/director-award-of-share-options-v0qz3514veilabd.html

I cannot see any reference to performance criteria so I assume it did not change.

So do LD’s options still have the same conditions attached to them? i.e. “Performance hurdle of 45p share price for 30 consecutive dealing days. In addition sale of company for in excess of £25 million”.

However, this would not explain how RG (as I understand it) is able to exercise his options. Maybe there is some sort of retirement clause in the options allowing him to exercise them?

No problem Wigwammer.

It is also worth pointing out that the 7 ovarian patients (44%) showing stable disease in the monotherapy cohort of 16 will not include the patients in the low dose Modi-1 Cohort 1. One of the 3 ovarian patients in this cohort also had stable disease (Certainly at week 8).

Lindy mentions near term inflection points 3 separate times in the RNS (The only inflections I have witnessed so far are downward ones : - ) ). But joking aside she would not do this without good reason:-

“Cash runway to 2H 2024 which covers near-term inflection points and cohort expansions”

“We remain well positioned and funded to continue the development of these high-potential assets to the next near-term value inflection points.”

“Due to the company increasing focus on its two clinical assets, Scancell is fully funded to 2H 2024 including the near-term data inflection points and near-term cohort expansions outlined above.”

Bermuda/Crumbs,

I believe we can account for 5 of the 8 patients in the other non ovarian monotherapy cohorts; these 5 will definitely have been scanned. Like Bermuda says all 8 have probably had their first 8 week scans. Trust me, I wish this was not the case.

RNS 21 February’23 is slightly later than the ASCO poster and includes 5 non ovarian patients, it states “To date, 23 patients have been vaccinated, 18 with HGSOC, two with TNBC, two with SCCHN and one with RCC, with 55 doses being administered in total.”

I believe the figure of 18 ovarian patients being vaccinated is correct. This includes 3 low dose Modi-1 patients in Cohort 1 and 15 in the monotherapy Cohort (One more monotherapy ovarian patient will have been dosed since then bringing it to 16).

16 will be the correct number for the ovarian monotherapy cohort (The 44% fits in with this i.e. 7 of the 16 having stable disease).

In the Guardian interview, talking about Modi-1, Lindy says:-

“It looks most promising as a treatment for head and neck cancer, where “surgery is quite debilitating and … it’s very disfiguring,” though Durrant cautions: “I don’t think it will be for every patient.”

However, Monday’s RNS only gives us this one liner about head and neck cancer:-

“One head and neck patient achieved a partial response and remains on study at week 37”

To make her comment in the Guardian Lindy clearly knows a lot more about the head and neck patients than this one liner in the RNS.

We know from the ASCO Poster that Cohort 3, Lower dose Modi-1 plus a checkpoint inhibitor, consisted of 3 head and neck patients:-

https://www.scancell.co.uk/Data/Sites/1/media/publications/posters/asco_modify-study-poster_april_final-2.0x.pdf

I suspect that all 3 of these patients had had at least one scan when Lindy spoke to the Guardian. I also suspect that the results were encouraging.

The following comment in Monday’s RNS, concerning ovarian cancer patients, also led me to the same conclusion:-

“Evaluation of Modi-1 plus checkpoint inhibitors in other tumour types in the ongoing Phase 1/2 study, WILL PROVIDE SUPPORTING DATA for this proposed combination use.” (Capital letters are mine for emphasis).

So not “MAY” but “WILL” provide supporting data.

Turning to Patient Y on the Macmillan website.

Patient Y is in Cohort 4, Full dose Modi 1 plus a checkpoint inhibitor (She is taking Nivolumab). I understand that she has renal cancer.

She had her first Modi 1 dose on Tuesday 6 June’23 (Day 1).

If you refer to the “ModiFY Study” website the first scan (Ignoring the initial pre-screening scan) for patients taking Modi 1 plus a checkpoint inhibitor, is due on visit day 64.

This scan is therefore due 8 August’23. She will have had 3 doses of Modi-1 by then. I don’t know how many doses of Nivolumab because this can be 2, 3, 4 or 6 weekly dosing.

Patient Y has been incredibly open about her experience on day 1 of her trial. I wonder if, like Trish, she will give us an update after that scan.

This timing fits in with the in the review meeting referred to in Monday’s RNS which states:-

“Subject to a safety committee review meeting scheduled to take place in August, this cohort will be expanded to 21 patients in both head and neck and renal cancer. Preliminary topline data from these cohorts is expected to be reported in 2024.”

On 9 September’21 LD received 6,840,633, joint ownership shares previously awarded to her through the Scancell Employee Benefit Trust. Subject to completion of that transfer Professor Durrant agreed to sell the Shares in two separate off-market transactions. Redmile purchased 4,459,681 of the Shares at 20.38p pence per share and a private individual purchased 2,380,952 shares at 21 pence per share.

LD will have received total sale proceeds of £1,408,883 (before tax if any).

Yes LD recently had a family holiday in Florida and she once inadvertently hired a limousine. However, I suspect she can afford the £173,250 to exercise her 4.5 pence share options.

Going from the chart on page 12 of the AGM presentation I expected Triple Negative Breast cancer to go into a combination cohort with a checkpoint (as is happening with head and neck and renal):-

https://scancell.co.uk/Data/Sites/1/media/docspres/agm-presentationnovember-2022_final.pdf

The little information we have on TNBC seems encouraging. The RNS states “One TNBC patient remains on trial with stable disease beyond 8 weeks”.

Also a new name, Professor David Cameron appeared on the ASCO poster (I mentioned this at the time):-

https://www.scancell.co.uk/Data/Sites/1/media/publications/posters/asco_modify-study-poster_april_final-2.0x.pdf

If you look at the following link he is very prominent in the field of breast cancer:-

https://www.ed.ac.uk/profile/david-cameron

Lindy makes no reference to TNBC when she says this in the Proactive interview:-

“In ovarian cancers check point inhibitors are not indicated at this point. So we think what we’ll do is continue with the other indication, now that’s both head and neck and renal, in combination with a checkpoint. Validate that approach, that combination of those, and then perhaps go back to ovarian and see if we can do that as well.”

I have tried to make sense of this from the trial numbers. The clinical trial website states 144 participants. Both RNS’s and the new “Modify Study” website refer to up to 138 patients (The difference of 6 is probably the 3 low dose patients in cohort one plus the 3 low dose combination patients in cohort three).

Working with 138 patients. Deduct the 30 in the pre surgery Head and neck cohorts and deduct the 64 in the 4 monotherapy cohorts (of 16 patients each). That leaves us with 44 patients.

According to the AGM slide there were going to be 3 combination cohorts (Modi + CPI) of 21 patients in Renal, Head and Neck and Triple Negative. That cannot be correct because that is 63 patients and there are only 44 patients left. That would give us 2 combination cohorts of 21 patients = 42 patients (I cannot account for the 2 remaining patients?).

The only explanation I can see is that the AGM slide was wrong and it was never the intention to trial moditope with a CPI in TNBC patients.

I think that Lindy is only re-iterating what she said in the Guardian interview 20 June’23:-

“If the trials work well, a Nasdaq listing in New York would be “a realistic opportunity” to raise more money, Durrant says. “The Americans are much more into high-risk, high-reward investments. The UK is much more conservative.”

I am not an expert at this but my interpretation is as follows. If the trials work well, the share price should then rise. Scancell would then do a Nasdaq listing at a higher less dilutive share price. (Much better than a highly dilutive cash raise at current share price levels).

How refreshing to see Scancell attending an event and presenting more up to date data rather than data from 4 months previously. (E.g. At ASCO in early June’23 Scancell presented a poster with data from early February’23):-

“Scancell has developed a novel technology platform for producing monoclonal antibodies that recognise glycans with high specificity and affinity. The platform has generated revenues and the antibodies continue to yield compelling results which have led to a new 6-month evaluation by a leading Biotech company. Additional in-house data has illustrated the potential of our antibodies as chimeric antigen receptor T cell (CART) therapies providing the data for a deal with a cell therapy company. These results along with updates on SCIB1 and Modi-1 will be presented at the AACR-CIMT meeting in Milan in September 2023.”

Konar,

I apologise. I typed my 11.05 on a word document then I pasted it onto this bb. It was only then that I saw your 10.59.

A couple of things stood out to me:-

I wonder if Scancell have had a milestone payment (or payments) from Genmab. The RNS states “The platform has generated revenues……”. “Revenues” in the plural implies more than just the initial £5.3 million upfront payment. This would further explain Scancell now being fully funded to 2H 2024 (The year ended 30 April’22 stated "The Directors’ cashflow projections indicate planned activities are fully funded through to Q1 2024").

Separately, it is interesting that Scancell are looking at using Modi-1 plus checkpoint inhibitors in ovarian cancer:-

“The number of patients who have experienced long periods of stable disease following monotherapy with Modi-1 is encouraging in this difficult to treat cancer and the Company believes that combination therapy with checkpoint inhibitors, which are not currently approved for the treatment of ovarian cancer, could further improve outcomes for this patient group. Evaluation of Modi-1 plus checkpoint inhibitors in other tumour types in the ongoing Phase 1/2 study, will provide supporting data for this proposed combination use.”

My initial thoughts were this is all about personalised vaccines again. Perhaps the Government are blinkered and can’t see what Scancell are doing in their own back yard.

However, one sentence in the article stood out to me:-

“Other personalised cancer vaccines could be off-the shelf products. These target common abnormalities in the respective types of cancer.”

It reminded me of something Prof Ottensmeier said in the Trish article (His reference to personalised therapies confused me at the time):-

“We are delighted that this treatment is working so well for Trish. It is very early days with this therapy and there is a long way to go before this can become a standard treatment for this cancer. But we are very hopeful that personalised therapies to combat cancer can become a reality in the patients we treat here at Clatterbridge.”

For ease of reference this is the link:-

https://liverpoolhealthpartners.org.uk/retired-nurse-given-lifeline-by-clinical-research-trial/

It also reminded me of Lindy’s response to a very good question raised by Chester at the AGM about BioNTech and the T cells they wanted from the ModiFY study. Lindy said “Good question, really good question, the simple answer is yes they are still interested and yes we can harvest them, science group are doing that as we speak. They are even more interested in the vaccine though cause that’s a simpler and cheaper way forward; so if we continue to get good clinical data they will definitely be one of the companies that we will engage with. Yes still interested but still early days.”

Maybe Scancell are currently negotiating some sort of deal with BioNTech and will in due course, when the time is right, announce that they are part of this agreement with the Government.

Like Scancell, the UW Medicine Cancer Vaccine Institute in Seattle appears to be working on non personalised cancer vaccines:-

https://economictimes.indiatimes.com/news/science/the-next-big-advance-in-cancer-treatment-could-be-a-vaccine/articleshow/101270336.cms?from=mdr

"However, the cost of such vaccines will be high" (Talking about personalised mRNA).

"You basically have to make every vaccine from scratch. If this wasn't personalized, the vaccine could probably be made for pennies, just like the COVID vaccine," said Dr. Patrick Ott of Dana-Farber Cancer Institute in Boston.

The vaccines under development at UW Medicine are designed to work for many patients, not just a single patient. Tests are underway for early and advanced breast cancer, lung cancer, and ovarian cancer.

For a vaccine to work, it needs to teach the immune system's T cells to recognize cancer as dangerous, said Dr. Nora Disis of UW Medicine's Cancer Vaccine Institute in Seattle. Once trained, T cells can travel anywhere in the body to hunt down danger.

"If you saw an activated T cell, it almost has feet," she said. "You can see it crawling through the blood vessel to get out into the tissues."

Hi Chester,

Just coming back to you on your 09.48 (Sorry for the delay, I’ve been out today). To be honest with you I stopped keeping notes on ModiFY timelines as I had been hoping for an update from Scancell. However, I’ve had another look back to see if I could establish anything.

It is 17 weeks today since the RNS 21 February’23. At the time 23 patients had been dosed, with 14 of these reaching the first imaging evaluation time point at week 8. These 14 consist of:-

1 Head and neck (SCCHN); this patient had a partial response.

12 Ovarian cancer (HGSOC) (Note: 3 of these were in Cohort 1); 6 had stable disease and 6 had progressive disease.

1 Triple negative breast cancer (TNBC) patient; this patient had stable disease.

There is a scan at initial screening then at weeks 8, 16, 25 and then every 12 weeks. Modi-1 doses are day 1, then weeks 4, 7,13, 25 and then every 12 weeks. It therefore follows that:-

14 of these patients will now have had their week 25 scan (i.e. 17 weeks since week 8 scan) and will have had 5 Modi-1 doses.

The remaining 9 patients (i.e. 23 minus 14) will all have had their week 16 scan and will have had 4 Modi-1 doses.

(These 9 consist of :- 1 Head and neck, 4 Ovarian, 1 Triple negative breast cancer and 3 Head and neck with a checkpoint inhibitor in Cohort 3).

Cohort 3 must have gone well because:-

1. The ASCO poster tells us patients are being screened for Modi-1 + standard of care checkpoint inhibitor (Cohort 4).

2. In the Guardian Lindy says It looks most promising as a treatment for head and neck cancer, where “surgery is quite debilitating and … it’s very disfiguring”, though Durrant cautions: “I don’t think it will be for every patient.”

We don’t know how many new patients have been dosed in the 17 weeks since the RNS. However, I suspect that ovarian patients are now fully recruited.

Hopefully something is brewing. I see that the caption under Lindy’s photograph in the Guardian says it was taken in May’23 by Sophie Evans of The Observer. I suspect that the interview was the same day with an embrgo on the story’s release.

No problem and no need to apologise Cleaner.

Our friends from Innovate UK are also there:-

Karen Spink, PhD, Head of Medicines, Innovate UK

"This session will introduce Innovate UK’s £30m bespoke funding programme for UK entrepreneurs delivering next-generation cancer therapies, with a focus on immunotherapies and paediatrics. We will also hear from an exciting startup, Infinitopes, who are being supported through this programme to pioneer high-efficiency cancer vaccines. The successful translation and commercialisation of medical discoveries will transform patient care and grow the UK’s position as a global science and technology superpower".

I was wondering if anyone can throw any light on this?

MymAb Biologics are exhibiting at the above event. They are number 6 on the floor plan:-

https://www.immuno-oncologyeurope.com/docs/librariesprovider33/sponsorship-and-exhibit-files/23/2023-imxe-floor-plan.pdf

Lindy appears to be linked to MymAb Biologics. You will see her photo at the bottom of the page on their website:-

https://www.mymab.net

I also found Lindy on this paper naming Lindy (linked to MymAb Biologics.and Nottingham University):-

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9575314/

The ASCO poster (Showing information as at early February’23) tells us that 13 patients had been evaluated:-

1 Head and neck (SCCHN); this patient had a partial response.

12 Ovarian cancer (HGSOC) (Note: 3 of these were in Cohort 1); 6 had stable disease and 6 had progressive disease.

The RNS 21 February’23 tells us that 14 patients had been evaluated. It states “Modi-1 cancer vaccine showed partial response and stable disease in patients with hard-to-treat head and neck, high grade serous ovarian or triple negative breast cancers”. (Note no mention of renal cancer, so no renal cancer patient had been evaluated). It also states “Of these patients, one has had a confirmed partial response and seven patients have stable disease, despite having progressive disease prior to enrolment in the study”.

This tells us that patient 14 evaluated was:-

1 Triple negative breast cancer (TNBC) patient; this patient had stable disease.

A strong endorsement from within Scancell:-

Scancell have put the ASCO poster on Linked-in.

A scientist, Imuno-Oncology at Scancell (I won’t name him in case I breach any rules? but his name is on a number of Scancell vaccine publications) has made the following comment against the poster:-

“I strongly support and believe in our Modi-1 vaccine potency to treat head/neck, breast, renal and ovarian cancer”.

The poster is now on Scancell's website. It only gives information as at early February'23:-

https://www.scancell.co.uk/Data/Sites/1/media/publications/posters/asco_modify-study-poster_april_final-2.0x.pdf